[Federal Register: July 6, 2004 (Volume 69, Number 128)]
[Notices]
[Page 40639-40640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy04-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0033]
Establishing a Docket for the Factor VIII Inhibitor Public
Workshop; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to receive information and comments on the November
21, 2003, public workshop entitled ``Factor VIII Inhibitors'' (the
workshop). We are opening the docket because there was insufficient
time available during the workshop for a full discussion of the many
important topics covered at the workshop.
DATES: Submit written or electronic comments on the workshop, related
regulatory and scientific issues, and comments on information submitted
to the docket by other interested parties by January 6, 2006.
ADDRESSES: Submit written comments and information related to the
workshop to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852-1448.
Submit electronic comments or information to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for
electronic and other access to the slide presentations and transcript
from the workshop.
FOR FURTHER INFORMATION CONTACT: Sharon Carayiannis, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 20, 2003 (68 FR 59942), we
published a notice to announce a public workshop entitled ``Factor VIII
Inhibitors.'' On November 21, 2003, we, in cosponsorship with the
International Association for Biologicals, held the workshop to address
regulatory and scientific concerns about inhibitors to Factor VIII
induced by Antihemophilic Factor (Factor VIII) products. These
inhibitors arise in a significant minority of patients with hemophilia
and make replacement therapy problematic. The workshop covered a broad
range of
[[Page 40640]]
topics. The workshop provided valuable information, but additional time
was needed at the close of the meeting for continued dialogue on
important topics. At the end of the workshop, we invited written
comments to provide an opportunity for a full discussion of issues.
We have established this docket to encourage interested parties to
continue to provide information about Factor VIII inhibitors, comments
on the workshop, and comments on information submitted to the docket by
other interested parties. We also request that those who have already
submitted written comments and information to FDA resubmit the same
comments to the docket to ensure their adequate consideration since
this information was not previously submitted to the docket. We also
posted this request for comments and information at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/meetings/fctrvIII112103L.htm
.
Comments submitted to the docket will assist us in determining the
need for and feasibility of establishing new inhibitor assay standards
and methodologies, stakeholders' opinions about current upper and lower
limits of acceptable inhibitor formation in clinical trials, and the
use of plasma-derived versus recombinant Factor VIII controls in
pharmacokinetic trials, among other issues. We may also consider the
information in preparing any future guidance on clinical trials to
evaluate potential inhibitor formation from Factor VIII products.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the workshop.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of this notice, the slide
presentations and transcript from the workshop, and received comments
are available for public examination in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the slide
presentations at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/summaries.htm and the transcript of the workshop at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: June 24, 2004.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15135 Filed 7-2-04; 8:45 am]
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